Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02530502 : Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histologically confirmed newly diagnosed glioblastoma; patients with an initial
diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined
to be glioblastoma and they received no prior treatment

- No prior treatment with radiation or chemotherapy for their GBM

- No prior treatment with carmustine wafers

- Patients who have undergone recent surgery:

- Must be a minimum of 14 days from surgery

- Craniotomy or intracranial biopsy site must be adequately healed and free of
drainage or cellulitis, and the underlying cranioplasty must appear intact at
the time of registration

- Magnetic resonance imaging (MRI) within 72 hours of surgery OR 4 weeks from
surgery

- Karnofsky performance status >= 70%

- Stable or decreasing dose of corticosteroids within 5 days prior to treatment

- Female subject of childbearing potential should have a negative urine or serum
pregnancy within 7 days prior to receiving the first dose of study medication; if the
urine test is positive or cannot be confirmed as negative, a serum pregnancy test
will be required

- Patients need not have measurable or evaluable disease

- Absolute neutrophil count (ANC) > 1.5 x 10^9/L

- Platelet count > 100 x 10^9/L; or

- Hemoglobin (Hb) > 9.0 g/dL within 7 days prior to enrollment; note: the use of
transfusion or other intervention to achieve Hb >= 9 g/dL is acceptable

- Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients diagnosed
with Gilbert's disease)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]),
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5
x ULN

- Alkaline phosphatase (ALP) =< 2.5 x ULN

- Serum creatinine < 1.5 x ULN

- International normalized ratio (INR), prothrombin time (PT), or activated partial
thromboplastin time (APTT) as follows: in the absence of therapeutic intent to
anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN; in the
presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT
within therapeutic limits (according to the medical standard in the institution) and
the patient has been on a stable dose of anticoagulants for at least 2 weeks before
registration

- Females of child-bearing potential (FOCBP) and males must agree to use two adequate
contraception methods (give examples, e.g. hormonal or barrier method of birth
control; abstinence) prior to study entry, for the duration of study participation,
and for 120 days following completion of therapy; should a female patient become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately

- NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a
tubal ligation, or remaining celibate by choice) who meets the following
criteria:

- Has not undergone a hysterectomy or bilateral oophorectomy

- Has had menses at any time in the preceding 12 consecutive months (and
therefore has not been naturally postmenopausal for > 12 months)

- Patients must have the ability to understand and the willingness to sign a written
informed consent prior to registration on study

Exclusion Criteria:

- Any prior treatment for the patients GBM

- Has a known diagnosis of immunodeficiency (human immunodeficiency virus [HIV] 1/2
antibodies) or any other form of immunosuppressive therapy within 7 days prior to the
first dose of trial treatment excluding steroids; attempts should be made to have
patient on lowest possible dose of steroids

- History of another malignancy in the previous 3 years, with a disease-free interval
of < 3 years; exceptions include basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or in situ cervical cancer that has undergone potentially
curative therapy

- Has an active autoimmune disease requiring systemic treatment within the past 3
months or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic steroids or immunosuppressive agents; subjects with vitiligo
or resolved childhood asthma/atopy would be an exception to this rule; subjects that
require intermittent use of bronchodilators or local steroid injections will not be
excluded from the study; subjects with hypothyroidism stable on hormone replacement
or Sjogren's syndrome will not be excluded from the study

- Has evidence of or a history of interstitial lung disease, non-infectious pneumonitis
or pneumonitis

- Has an active infection requiring systemic antibiotics within 7 days of registration

- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator;
examples include

- Hypertension (defined as 160/95) that is not controlled on medication

- Ongoing or active infection requiring systemic treatment

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations or substance abuse disorders that would
limit compliance with study requirements

- Any other illness or condition that the treating investigator feels would
interfere with study compliance or would compromise the patient's safety or
study endpoints

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment

- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways)

- Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or
hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is
detected)

- Has received a live vaccine within 30 days prior to the first dose of trial treatment

- Patients receiving any other investigational agents within 30 days prior to the first
dose of trial treatment

- Patients who have a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to MK-3475 are not eligible; known hypersensitivity
to any excipients of MK-3475
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02530502      |      Link to official Clinicaltrials.gov listing
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